Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence

Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence: Study Protocol of a Randomized Controlled Trial

Few studies have tailored psychological intervention for fear of cancer recurrence (FCR) in young breast cancer patients, and the long-term efficacy of psychological intervention and its underlying mechanism are still unknown. To fill this knowledge gap, this protocol aims to evaluate the short-term and long-term effectiveness of Fear-focused Self-Compassion Therapy, as well as this therapy's psychological and physiological mechanisms in reducing severe FCR in young women with breast cancer.

This study will be a randomized controlled trial recruiting 160 Chinese young female breast cancer patients with severe FCR. Participants will be randomized to the Fear-focused Self-Compassion Therapy group or control group (1:1). Measurement will be completed at baseline (T0), immediately completing intervention (T1), after 3 months (T2), after 6 months (T3) and after 12 months (T4). Primary outcomes are FCR severity; secondary outcomes are self-compassion, neurophysiological data (i.e., salivary alpha amylase and heart rate variability), attentional bias for FCR, rumination, catastrophizing thinking, and psychological symptoms. The Fear-focused Self-Compassion Therapy is based on the theories of FCR development and self-compassion, and consists of eight-week face to face group sessions.

Study Overview

• Status: Recruiting
• Conditions: Fear of Cancer Recurrence
• Intervention / Treatment: Behavioral: Fear-focused Self-Compassion Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Zhu, PhD; Phone Number: +8615091199645; Email: lei.zhu@snnu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Recruiting
      • Shaanxi Provincial Cancer Hospital
      • Contact: Juntao Yao; Email: 1278748172@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• (1) are diagnosed with breast cancer (including various cancer stages and subtypes);
• (2) are aged 18-45 years;
• (3) can sign written informed consent;
• (4) can read and write Chinese;
• (5) have severe FCR, with scores > 13 on the FCRI severity subscale.

Exclusion Criteria:

• (1) currently have psychiatric and psychological illness;
• (2) have other types of tumor;
• (3) had a previous cancer recurrence;
• (4) are participating another psychological intervention at the start of the study or during their eight-week therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fear-focused Self-Compassion Therapy; Experimental group receives group face-to-face Fear-focused Self-Compassion Therapy for eight weeks.	Behavioral: Fear-focused Self-Compassion Therapy; The Fear-focused Self-Compassion Therapy will be delivered as a group format. The intervention consists of eight group face-to-face sessions (60-90 minute for each session) and will be delivered by three trained therapists for eight weeks (sessions are weekly). Each intervention group involves 10 patients.
No Intervention: Usual care; The no intervention group receives usual care supported by hospital or coming from elsewhere for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of cancer recurrence (FCR)	Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.	Baseline
Change from Baseline Fear of cancer recurrence (FCR) after immediately completing intervention	Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.	After immediately completing intervention
Change from Baseline Fear of cancer recurrence (FCR) at 3 months	Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.	Baseline to 3 months
Change from Baseline Fear of cancer recurrence (FCR) at 6 months	Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.	Baseline to 6 months
Change from Baseline Fear of cancer recurrence (FCR) at 12 months	Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-compassion	Self-compassion will be measured by using the 12-item Self-compassion Scale-Short Form (SCS-SF) consisting of six facets: self-kindness (2 items), self-judgement (2 items), common humanity (2 items), isolation (2 items), mindfulness (2 items) and over-identification (2 items) . Responses were rated on a five-point scale from 1 (almost never) to 5 (almost always).	Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.
Salivary alpha amylase	The salivary alpha amylase activity will be measured by using a hand-held salivary alpha amylase monitor manufactured by Nipro (Osaka, Japan). This analyzer can automatically measure the salivary alpha amylase activity within one minute (about 30 seconds for saliva collection and 30 seconds for analyzing). Participants will be asked to brush teeth before measurement and not allowed to intake any food, beverage, tobacco or liquor within an hour.	Baseline and immediately completing intervention
Heart rate variability (HRV)	The HRV will be measured by using signal detection and amplification system (Biopac ECG100C) of MP150-Biopac data acquisition system. The CardioBatch will be used to compute the HRV. Participants will be asked not to intake any stimulant (e.g., caffein, alcohol), or cannot do any strenuous activity within four hours before measurement.	Baseline and immediately completing intervention
Attentional bias for FCR	Attentional bias for FCR will be assessed by conducting the dot-probe task, including 200 trials with the stimuli of cancer-related words and utilized in previous study. The dot-probe task will be presented on a laptop computer and run by using Matlab. At the beginning of each trial, a "+" will present for 500 milliseconds in the center of the screen. After that, a pair of word stimuli with a neutral word (e.g., apple) and a cancer-related word (e.g., chemotherapy) will be presented for 500 milliseconds on the left and right sides of screen. Then, the probe stimuli will be presented at the position where the word stimuli just appear. Once the probe stimuli appear, participants should press button of the keyboard as soon as possible. After that, the screen will present 500 milliseconds of blanking, and the next trial will start.	Baseline and immediately completing intervention
Rumination	Rumination will be measured by using the 4-item Cognitive Emotion Regulation Questionnaire Rumination Subscale (CERQ-RS). Each item of CERQ-RS ranges from 1 to 5. A higher total score means more severe rumination.	Baseline and immediately completing intervention
Catastrophizing thinking	Catastrophizing thinking will be measured by using the 4-item Cognitive Emotion Regulation Questionnaire Catastrophizing Subscale (CERQ-CS). Each item of CERQ-CS ranges from 1 to 5. A higher total score means more severe catastrophizing thinking.	Baseline and immediately completing intervention
Psychological symptoms	Psychological symptoms will be measured by using Hospital Anxiety and Depression Scale (HADS). This 9-item questionnaire consisting of both anxiety subscale and depression subscale, rates on five-point (0-4) scales. The total score ranges from 0 to 36, and a higher total score means more severe depression and anxiety symptoms.	Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.

Collaborators and Investigators

• Sponsor: Shaanxi Normal University
• Collaborators: Shanxi Provincial Cancer Hospital
• Investigators: Principal Investigator: Lei Zhu, PhD, Shaanxi Normal University; Study Director: Juntao Yao, PhD, Shanxi Provincial Cancer Hospital

Publications and helpful links

General Publications

• Wei L, Yang X, Sun S, Yu Y, Xie J, Zhao J, Wang X, Zhu L, Yao J. Fear-focused Self-compassion Therapy for young breast cancer patients' fear of cancer recurrence: Study protocol of a randomized controlled trial. Front Psychiatry. 2022 Sep 23;13:941459. doi: 10.3389/fpsyt.2022.941459. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: RCT; Fear of Cancer Recurrence; Self-compassion Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: Self-compassion FCR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No